Why EMA has done read-across for N-nitroso-desmethyl-doxylamine?

[Muzaffar]

N-Nitroso-desmethyl-doxylamine belongs to the category of N-Nitroso-N-methyl-N-alkylaryls for which an AI of 100 ng/day has been accepted based on a read-across with NNK.

No, you cannot assign an AI of 100 ng/day for all Potency Category 1 NDSRIs without in vivo data. I am tagging the relevant string on this topic.

N-nitroso-N-methyl-N-alkylaryls

FDA recently added nitroso-desmethyl-diltiazem to Table 2, and set an AI of 100 ng/day by read across from NNK. Now, not only nitroso-oxetines can be read a cross from NNK. Now it is the time to use NNK as a surrogate for all N-nitroso-N-methyl-N-alkylaryl NDSRIs and start moving away from the 18/26.5 ng/day AI for NDSRIs in general.